Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Claims 1-18 are currently pending and a preliminary amendment to the claims filed on 10/30/20243 are acknowledged.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The two (2) information disclosure statement (IDS) submitted on 02/07/2025; 08/21/2025 were filed before the mailing date of the instant first action on the merits. The submission thereof is in compliance with the provisions of 37 CFR 1.97. It is noted that the foreign references have only been considered to the extent that an English language abstract, translation or statement of relevance has been provided to the examiner. Accordingly, the information disclosure statement has been considered by the examiner, and signed and initialed copy is enclosed herewith.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “the solid composition” in line 2, but which lacks sufficient antecedent basis because claim 1 does not recite “a solid composition”.
Claim 5 recites “the composition or film”, but which lacks sufficient antecedent basis because claim 1 does not recite “a film”.
Each of claims 6 and 9 recites “the anionic surfactant”, but which lacks sufficient antecedent basis because claim 1 does not recite “an anionic surfactant”.
Claim 11 recites “organic esters such as triethyl citrate and diethyl phthalate”, but which is indefinite. It is noted that a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 11 recites the broad recitation “organic esters”, and the claim also recites “triethyl citrate and diethyl phthalate” which is the narrower statement of the range/limitation. This claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
The remaining claims are also rejected due to the rejection of base claim 1.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4, 6-9, 13 and 15-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhao et al., “Effect of sodium lauryl sulfate in dissolution media on dissolution of hard gelatin capsule shells”, Pharmaceutical Research, vol. 21, no. 1, January 2004.
Applicant claims the below claim 1 filed on 10/30/2024:
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Prior Art
Zhao discloses that sodium lauryl sulfate (SLS) surfactant reading on the claimed anionic surfactant having C12 alkyl chain moiety and sulfonic group slowed down dissolution rate in gelation capsule shell in which the capsule reads on the claimed film; in particular, when Zhao investigated that sodium acetate or sodium phosphate buffer as a dissolution media reading on the claimed aqueous medium was used with or without SLS to cover the pH range of 1-7 (page 144 – right column), it was found that SLS interacts with gelatin to form a less-soluble precipitate at pH <5, and that is, SLS significantly slowed down the dissolution of gelatin capsule shells at pH <5 due to decreased conformation stability of gelatin rather than the increased positive net charge, and on the other hand, the dissolution rate of gelatin shells at pH >5 (e.g., pH 5-8) is not decreased which reads on the claimed dissolution at pH 6.8 is higher than the dissolution rate at pH 1 (abstract on right column page 144, left column and Fig.1 on page 245 and right column on page 147, and Conclusion, right column on page 148). Here, the instant pH range of 6.8 is within the pH range of 5-8 or pH>5 and the instant pH range of 1 is within the pH range of pH <5. (instant claims 1-2, 4, 6 and 9); Figs. a on page 145 shows effect of 1% SLS on the dissolution of hard gelatin capsule shells at 37C at pH 1 (=0.1N HCl) wherein 80% or less dissolution was within 60 minutes or 120 minutes embracing 70 or 90 minutes (instant claims 3 and 16); 30% w/w gelatin solution (type A or type B) and 1% SLS was used (left column, page 144); the SLS surfactant is sulfate ester (instant claim 7); the SLS has molecular weight of 288.38g/mol as evidenced by attached SLS Safety Data Sheet (see page 4) that is within the claimed range of 250-600g/mol (instant claim 8); the capsule is hard gelatin capsule shell that is seen as film (see entire document including abstract and conclusion) (instant claim 13); the shell film is the outer layer of the capsule (instant claim 15); according to Fig. 1, at 37C and at pH 1 (=0.1N HCl), the dissolution rate within 60 minutes embracing 20 or 30 minutes is 70% or less (see Fig. 1a on page 145) that is within the instant range of 50% or less or 80% or less and at 37C and at 37C and at pH 6.8, the dissolution rate within 45 minutes is 80 to less than 100% (see Fig. 1f on page 145) which is within the instant range of 50% or more (instant claims 17-18).
In light of the foregoing, instant claims 1-4, 6-9, 13 and 15-18 are anticipated by Zhao.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
As indicated above, the present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over Zhao et al., “Effect of sodium lauryl sulfate in dissolution media on dissolution of hard gelatin capsule shells”, Pharmaceutical Research, vol. 21, no. 1, January 2004 as applied to instant claims 1-4, 6-9, 13 and 15-18 in view of Ahmad et al., (WO2017/095736A1).
Applicant claims the below claim 1 filed on 10/30/2024:
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Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a medical/pharmaceutical research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from medicine, pharmacy, physiology and chemistry— without being told to do so.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art (MPEP 2141.01); Ascertainment of the difference between the prior art and the claims (MPEP 2141.02); and Finding of prima facie obviousness Rational and Motivation (MPEP 2142-2143)
Zhao was discussed above with respect to instant claims 1-4, 6-9, 13 and 15-18.
However, Zhao does not expressly teach 30-80% of gelatin amount and 8% or more of anionic surfactant of instant claims 5 and 10; and plasticizer and its amount of instant claims 11-12, and encapsulating filling material comprising a food supplement or an active pharmaceutical ingredient of instant claim 14. The deficiencies are cured by Ahmad.
Ahmad discloses gelatin capsule containing aspirin, surfactant and plasticizer (see entire document including claims 1 and 8) wherein the capsule shell contains gelatin from about 10 to about 70% ([0012]) that overlaps the instant range of 20-80% MPEP 2144.05 noted above, and the surfactant includes SLS ([0013]-[0014]) and it is used in an amount of about 0.01 to about 10% ([0051]) that overlaps the instant range of 8% or more of instant claim 5 and 30% or less of instant claim 10. MPEP 2144.05 states that [I]n the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976) (instant claims 5 and 10), and the plasticizer includes glycerol, sorbitol, propylene glycol, etc. ([0015] and claim 10 of prior art) and is used in an amount of about 10-about 30% ([0032]) that overlaps the instant range of 10-40% of instant claim 12. See MPEP 2144.05 above (instant claims 11-12); and the aspirin as a filling active pharmaceutical agent is encapsulated by gelatin shell (Fig. 1) (instant claim 14).
It would have been obvious to optimize the amounts of gelatin and surfactants of the applied art with the claimed amounts because the applied art teaches overlapping amounts and further increasing their amounts vary depending on the intended purpose, formulation type, relationship with other ingredients, etc., in the absence of criticality evidence of the claimed range.
Additionally, it would have been obvious to modify the teachings of Zhao with addition of plasticizer of Ahmad. One of the ordinary artisan would have been motivated to do so because added plasticizer would have enhanced properties of the gelatin capsule.
Further, it would have been obvious to modify the gelatin capsule by placing the filling material, e.g., active agent aspirin in the core of the capsule for oral administration to treat certain disorders and diseases, as taught by Ahmad.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYUNG S CHANG whose telephone number is (571)270-1392. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Yong (Brian-Yong) S Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYUNG S CHANG/ Primary Examiner, Art Unit 1613